Tuttlingen - In September 2020, the Med Alliance BW launched by MedicalMountains GmbH started its work. Looking back at the past twelve months is above all a look ahead - at the challenges of medical technology and how they can be met in close collaboration. Several large publications have been made for companies that are passively involved.

The term Med Alliance BW stands for “Nationwide expert initiative for the joint implementation of regulatory requirements in medical technology”, abbreviated to Lexi. It is the core committee in the project funded by the Baden-Württemberg Ministry of Economics, Labor and Tourism as part of the Baden-Württemberg Health Location Forum.

The fact that 18 medical technology companies are currently working together could be described as a “think tank for practice” - “but above all as a successful concept”, summarizes MedicalMountains managing director Julia Steckeler: “Companies help each other. You don't see any competition, you sit down at a table to find solutions. ”Checklists, FAQ documents and contract templates have been created over the past few months. And after a year, the Med Alliance BW is drawing ever wider circles. "Many specialists have recently joined the company so that the various topics can be dealt with with incredible depth," reports Julia Steckeler. What is anything but self-evident right now: “The Lexi companies are also in the middle of implementing the MDR. And yet they find the resources to expand their commitment. ”That says a lot about motivation.

What is particularly preoccupying the industry at the moment is reflected in the current ten working groups (see information box). Particularly extensive publications are available, for example, in the areas of PMCF and biocompatibility before completion - and thus also available to passive companies. You have registered for a fixed annual fee with Med Alliance BW and benefit from it in several ways. Julia Steckeler highlights three aspects. First and foremost: "It is important that a noticeable financial and personnel relief arrives", so that one can increasingly turn to other, future-oriented topics. Second: "You gain experts and thus new skills without expanding your staff." Lexi is therefore often referred to as "the invisible co-thinker and employee". Thirdly: "We set standards to ensure that cooperation within the entire industry is based on trust." For example, with the quality assurance agreement that has been in circulation for a long time or the recently published material compliance checklist. “The Med Alliance BW is perceived as a neutral body. The points formulated in the documents are not based on an individual whim, but are firmly based on regulatory requirements. In this way, the parties meet on an equal footing, ”says Julia Steckeler. Arousing understanding, promoting cooperation, building partnerships: "If we make a contribution with the Med Alliance BW, a great deal will be gained." And the topics, she is convinced, would not run out in the next twelve months either.

Passive companies from all over Germany can still register with Med Alliance BW. More information at this link .

Currently active working groups:

  • Biocompatibility
  • EUDAMED
  • Implant register
  • Supplier management
  • Material compliance
  • PMCF
  • UDI
  • UDI international
  • International approval

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